Senior Director of Regulatory Affairs
Shama Munim
Ms. Munim is a global regulatory affairs leader with over a decade of progressive experience across all phases of drug development, including a strong focus on rare diseases, and leadership of multiple NDA / BLA / IND / CTA submissions and approvals. She has extensive experience in regulatory strategy, expedited pathways, and health authority engagement with the FDA, EMA, and MHRA.
Prior to Palvella, Ms. Munim led regulatory strategy at Korro Bio and Centessa Pharmaceuticals. Before this, she was responsible for regulatory affairs at Fortress Biotech, which is focused on acquiring, developing, and commercializing development-stage pharmaceutical products. Ms. Munim worked across several of the Fortress subsidiaries, including Cyprium Therapeutics, Mustang Bio, and Caelum Biosciences. Most notably, during her time at Cyprium, she led regulatory efforts that resulted in the approval of ZYCUBO® (copper histidinate) as the first FDA-approved treatment for Menkes disease, a rare pediatric disease. Ms. Munim guided the program through an innovative single-arm NDA supported by historical controls, securing multiple expedited designations, including Breakthrough Therapy, Fast Track, Orphan Drug (US & EU), Rare Pediatric Disease, and a Priority Review Voucher. She began her career at Teva Pharmaceuticals, working across both regulatory affairs and program management.
Ms. Munim holds a B.S. in Pharmaceutical Sciences from the Massachusetts College of Pharmacy and Health Sciences, as well as an M.S. in Regulatory Affairs from Northeastern University.